Found Description
Job Summary
Provide project and study support to clinical teams by performing centralized monitoring, administrative tasks, data review, and system updates. Ensure all work aligns with SOPs, ICH-GCP, regulatory requirements, and project timelines.
Key Responsibilities
+ Complete required role training and follow all SOPs and quality standards.
+ Provide administrative support (run reports, maintain trackers, prepare status updates, follow up on outstanding items).
+ Update and maintain study systems and support compliance with project timelines.
+ Assist in preparing i-Site Packs and other study documents.
+ Perform centralized monitoring activities and assess site/data quality.
+ Monitor site performance metrics and follow up on missing data, queries, SDV backlog, and visit schedules.
+ Identify site-level risks and recommend/track corrective actions.
+ Conduct Subject Level Data Review (SLDR) and escalate issues as needed.
+ Perform ...
Provide project and study support to clinical teams by performing centralized monitoring, administrative tasks, data review, and system updates. Ensure all work aligns with SOPs, ICH-GCP, regulatory requirements, and project timelines.
Key Responsibilities
+ Complete required role training and follow all SOPs and quality standards.
+ Provide administrative support (run reports, maintain trackers, prepare status updates, follow up on outstanding items).
+ Update and maintain study systems and support compliance with project timelines.
+ Assist in preparing i-Site Packs and other study documents.
+ Perform centralized monitoring activities and assess site/data quality.
+ Monitor site performance metrics and follow up on missing data, queries, SDV backlog, and visit schedules.
+ Identify site-level risks and recommend/track corrective actions.
+ Conduct Subject Level Data Review (SLDR) and escalate issues as needed.
+ Perform ...
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